Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study

Purpose: We compared the hydrocoated silicone stent (Coloplast Imajin (R) hydro) to Percuflex (TM) Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup. Materials and Methods: This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J (R) stent removal at day (D) 20. Secondary end-points were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation. Results: The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p < 0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers. Conclusions: The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.